FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS CYSTOSCOPE
MDR report key: 3072899
·
Received April 5, 2013
Report
- Report Number
- 9610773-2013-00031
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Report Date
- March 11, 2013
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- FAJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, BUT WITH NO RESULT. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED DUE TO THE INSUFFICIENT INFO PROVIDED BY THE USER FACILITY. IF ADDITIONAL INFO IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem · 1
OLYMPUS WAS INFORMED THAT THE USER MAY HAVE LOST PARTS OF THE SUBJECT DEVICE WITHIN THE BODY CAVITY. THERE WAS NO FURTHER INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141524 | OLYMPUS CYSTOSCOPE | CYSTOSCOPE SHEATH | FAJ | OLYMPUS WINTER & IBE GMBH | A20911A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |